Three additional factors provided impetus to the Commission to revise the old Directive: (1) the 2005 World Health Organization Framework Convention on Tobacco Control, which is legally binding on the EU and its Member States; (2) the emergence of new products in the market, including electronic cigarettes and flavored tobacco products; and (3) new scientific evidence on flavors and on the impact of health warnings on consumption. (Press Release, European Commission - MEMO/14/134, Questions and Answers: New Rules for Tobacco Products (Feb. 26, 2014), EUROPA.)

The newly adopted Tobacco Products Directive regulates the manufacture, sale, and marketing of tobacco products. It is designed to facilitate the smooth functioning of the EU's internal market on tobacco products and to protect public health by making tobacco products less appealing, especially to young people. It is estimated that tobacco use causes 700,000 avoidable deaths annually in the EU. (Id.)

Some highlights of the new Directive include:

Health Warnings

· Packages of tobacco products must carry a written text warning and a corresponding color picture that covers 65% of the front and back of the package. The general warning must state "Smoking Kills –Quit Now" and the message "Tobacco Smoke Contains over 70 Substances Known to Cause Cancer."

· EU Members have the option to exempt tobacco products (except cigarettes, roll-your–own, and water pipe tobacco, which will always carry the health warnings) from having the abovementioned warning and message.

· Cigarette packs will be required to have a cuboid shape to ensure the visibility of health warnings and each pack must contain a minimum of 20 cigarettes. (Id.)

Misleading Labeling

· There is a prohibition against misleading labeling containing the words "natural" or "organic" in general and on "lipstick type" packages in particular.

· Promotional advertising, including references to lifestyle benefits, is prohibited.

· Roll-your-own tobacco packs will also have to carry the 65% coverage combined health warning on the front and back of the package. (Id.)

Flavorings and Additives

· The addition of flavors in cigarettes and roll-your-own tobacco products in such quantities that they give the product a "characterizing" flavor other than tobacco is prohibited. Menthol is considered a characterizing flavor and its use will be banned completely after a four-year period.

· Cigars, cigarillos, and smokeless products are not subject to this restriction on flavors.

· Additives essential for the manufacturing of tobacco products are permitted. (Id.)

Obligations of Tobacco Makers

· There is a mandatory reporting requirement of ingredients on all tobacco products and of emissions of tar, nicotine, and carbon monoxide for cigarettes. The specific amounts of emission of tar, nicotine, and carbon monoxide for cigarettes, as well as other emissions, must be stated on the package. (Id.)

Tracking and Tracing System

· A tracking and tracing system and safety features are introduced for the first time in the Directive, to ensure that fake products are not circulated in the market and to combat illicit trade.

· EU Members have the option to prohibit cross–border, distance sale of tobacco products through mail-order companies. (Id.)

Electronic Cigarettes

· E-cigarettes that contain nicotine fall within the scope of the Directive.

· Health warnings on e-cigarette packaging will be mandatory.

· Manufacturers of e-cigarettes have to comply with safety and packaging requirements.

· Manufacturers must comply with the rules on misleading advertising.

· Manufacturers are required to report back to the Commission on sales volume and types of users of their tobacco products. (Id).

Entry into Force

The new Directive will enter into force in May 2014. EU Members have a period of two years to transpose the provisions into their national legislation, so that their laws conform to the Directive. Thus, the provisions of the Directive will be implemented nationally by the beginning of 2016. (Id.)

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